ABSTINENCE AND HIV/STD PREVENTION FOR YOUTH

Release Date: February 26, 1999

RFA:  MH-99-010

P.T.

National Institute of Mental Health
National Institute on Child Health and Human Development
National Institute on Nursing Research

Letter of Intent Receipt Date:  April 13, 1999
Application Receipt Date:  May 13, 1999

THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  THIS RFA INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA.

PURPOSE

The National Institutes of Mental Health (NIMH), National Institute on Child
Health and Human Development (NICHD), and National Institute on Nursing
Research (NINR) are encouraging applications for the support of theoretically
grounded research on interventions to prevent HIV/AIDS among children and
youth.  AIDS has become the sixth leading cause of death among youths between
the ages of 15 and 24.  This Request for Applications (RFA) is critical
because effective interventions must be developed to reduce HIV risk-related
behaviors in this vulnerable population.

Behavior change continues to be the primary way of reducing the spread of HIV. 
Prevention work with adolescents must reach sufficient numbers of this
population to change prevailing norms of sexual behavior.  Long-term
maintenance of behavior change is particularly critical in this group. 
Research submitted in response to this RFA should be based on an understanding
of the types and range of adolescent sexuality, the contexts in which youths
engage in social and sexual activities, perceived group norms about sexual
behavior, knowledge of and misperceptions about HIV risk among adolescents
from different groups, and adolescent attitudes toward safer sex practices. 
Culturally and developmentally appropriate interventions must be developed
that target a variety of outcomes (e.g., delay in initiation of sex, decreased
use of alcohol and illicit drugs, etc.) and that maintain behavior change over
the long term.  Particularly needed are interventions for high-risk subgroups
of adolescents and primary prevention interventions for HIV-infected
adolescents.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This Request for Applications (RFA),
Abstinence and HIV/STD Prevention for Youth, is related to the priority areas
of mental health and mental disorders, STDs and HIV/AIDS.  Potential
applicants may obtain a copy of "Healthy People 2000" at
http://www.crisny.org/health/us/health7.html

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and eligible
agencies of the Federal government.  Foreign institutions are not eligible for
the small grant (R03) mechanism.  Racial/ethnic minority individuals, women,
and persons with disabilities are encouraged to apply as Principal
Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research project
grant (R01) and small research grant (R03) award mechanisms. The total project
period for an R01 application submitted in response to this RFA may not exceed
five years.  R03 grants are limited to two years and are not renewable.  The
R03 are limited to $50,000 direct costs for each of these two years.

Specific application instructions have been modified to reflect the "MODULAR
GRANT APPLICATION AND AWARD" process which has been adopted by the NIH (see
the NIH Guide, December 15, 1998).

For this RFA, funds must be requested in $25,000 direct cost modules.  A
feature of the modular grant is that no escalation is provided for future
years, and all anticipated expenses for all years of the project must be
included within the number of modules being requested.  Only limited budget
information is required and any budget adjustments made by the Initial Review
Group will be in modules of $25,000.

More detailed information about modular grant applications, including a sample
budget narrative justification pages and a sample biographical sketch, is
available via the Internet at:
http://grants.nih.gov/grants/funding/modular/modular.htm

Responsibility for the planning, direction, and execution of the proposed
project will be solely that of the applicant.  Future unsolicited competing
continuation applications will compete with all investigator-initiated
applications and be reviewed according to the customary peer review
procedures.  The anticipated award date is August 30, 1999.

FUNDS AVAILABLE

The NIMH intends to commit approximately $1 million in direct costs to support
approximately three grants, NICHD commits $600,000 in total costs to support
one grant, and NINR commits $250,000 for one R01 or R03.  Because the nature
and scope of the research proposed may vary, it is anticipated that the size
of each award will also vary.  Although the financial plans of the Institutes
provide support for this program, awards pursuant to this RFA are contingent
upon the availability of funds and the receipt of a sufficient number of
applications of outstanding scientific and technical merit.

RESEARCH OBJECTIVES

Background

The major objective of research supported under this RFA is to develop
interventions that are effective in delaying initiation of sexual behavior. 
However, it is recognized that many youth will eventually become sexually
active and therefore interventions are needed to prevent HIV/STD risk-related
behaviors among children and youth, thereby preventing transmission of HIV. 
Although research has identified programs that have been successful in
increasing HIV/STD knowledge and recognition of risk among adolescents and
reducing their risk-related behaviors, little is known about the efficacy of
abstinence programs.  This RFA encourages prevention research focused on
abstinence-only programs.  This RFA will also entertain HIV/STD prevention
efforts that test abstinence-based and other more comprehensive sexuality
education interventions.  Such programs could include components that help
adolescents develop personalized knowledge about barriers to safer sex.  This
could be accomplished via individual or small-group counseling and education,
training in skills necessary for HIV-safe behavior (e.g., self-assertiveness,
sexual refusal, problem solving, behavioral self-management, etc.) providing a
supportive environment, and ensuring the accessibility of resources such as
health care.  Abstinence and other HIV/STD prevention programs that are found
to be successful can be tailored to the population or culture for which they
are intended and are developmentally appropriate.  Interventions proposed in
response to this RFA should be theory-based.

Areas of Interest

This section suggests areas of interest, but researchers responding to this
RFA need not limit themselves to these topics.

Among the questions that could be addressed are the following:

o  How does the type of intervention interact with the mode of delivery to
affect behavior change?  What are the "active ingredients" of these
interventions?

o  How do aspects of adolescent sexuality (e.g., curiosity, using sex to act
out angry feelings from other relationships or to maintain a relationship) and
their social context (e.g., peer pressure, media images, perceived group
sexual norms) facilitate or obstruct safer sex?  Which features lend
themselves to the development of effective interventions?

o  Which type of abstinence-only or abstinence-based HIV/STD interventions are
most effective for specific high-risk adolescent subgroups?  What components
of effective interventions are generalizable to different subgroups?

o  Are gender-specific abstinence interventions more effective with female
adolescents?  If so, what are the "active ingredients" of such interventions?

o  What are effective strategies embedded within an abstinence or other
HIV/STD prevention program to maintain abstinence or prevent relapse to high-
risk behaviors over the long term (e.g., relapse prevention paradigms and
motivational enhancement models from the substance abuse field)?  How can
initial interventions be improved so that behavior change lasts longer?

o  What is the "proper dose" of interventions to achieve commitment to
abstinence and maintain this behavior over the long term (e.g., how many
sessions, what intensity of intervention)?

o  What is the most appropriate/effective age at which to initiate HIV/STD
prevention programs?

o  Is there an optimal mix of school-based HIV/STD interventions and
community-based prevention activities?  Are community-based programs more
effective when delivered by faith communities, recreational groups, and/or
parent-oriented programs?

o How can interventions be designed to assist families support young people in
maintaining abstinence and/or safer sexual behavior?  Interventions should
specifically address issues of family dysfunction (e.g., substance abuse and
dependence in family, conflicts between adolescents and parents, lack of
family support for behavior change) and other factors that mediate HIV/STD
risk for adolescents.

o  What should the interventions target in different adolescent subgroups and
how can they best be measuredþdelay of sexual debut, maintenance of
abstinence, or reduction in risk-related behaviors (e.g., having sex without
condom use, having multiple sexual partners, using non-sterile injection
equipment)?

o  What are the effective components of an HIV testing and counseling program
for adolescents and can a "return to abstinence" message be built into these
prevention programs?  What factors are associated with early detection of
HIV/STDs and test-seeking behavior among adolescents?  What factors are
associated with returning for testing results?  Are there effective ways of
integrating testing and early detection with HIV/STD prevention programs?

INCLUSION OF WOMEN, AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and
their subpopulations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification is provided that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research.  This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research," which was published in the Federal Register of March 28, 1994 (FR
59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No.
11, March 18, 1994, available on the web at:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them. 
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html

Investigators also may obtain copies of the policy from the program staff
listed under INQUIRIES.  Program staff may also provide additional relevant
information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed research, the name, address, and telephone
number of the Principal Investigator, the identities of other key personnel
and participating institutions, and the number and title of the RFA in
response to which the application may be submitted.  Although a letter of
intent is not required, is not binding, and does not enter into the review of
a subsequent application, the information that it contains allows Institute
staff to estimate the potential review workload and avoid conflict of interest
in the review.

The letter of intent is to be sent to Dr. Pequegnat at the address listed
under INQUIRIES by the letter of intent receipt date listed in the heading of
this RFA.

APPLICATION PROCEDURES

Applicants are strongly encouraged to contact the program contacts listed
under INQUIRIES with any questions regarding the responsiveness of their
proposed project to the goals of this RFA.

The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants.  These forms are available at most institutional
offices of sponsored research and from the Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge Drive,
MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, Email:
GrantsInfo@nih.gov.  It is also available at:
http://grants.nih.gov/grants/forms.htm

BUDGET INSTRUCTIONS

o  FACE PAGE:  Items 7a and 7b should be completed, indicating Direct Costs
(in $25,000 increments) and Total Costs [Modular Total Direct plus Facilities
and Administrative (F&A) costs] for the initial budget period.  Items 8a and
8b should be completed indicating the Direct and Total Costs for the entire
proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398.  It is not required and will not be accepted with the
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398.  It is not required
and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page.
(See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) 
At the top of the page, enter the total direct costs requested for each year.

o  Under Personnel, list key project personnel, including their names, percent 
of effort, and roles on the project. No individual salary information should
be provided.

For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the nearest
$1,000. List the individuals/organizations with whom consortium or contractual
arrangements have been made, the percent effort of key personnel, and the role
on the project.  The total cost for a consortium/contractual arrangement is
included in the overall requested modular direct cost amount.

Provide an additional narrative budget justification for any variation in the
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a specific
role in the proposed project, as well as to evaluate the overall
qualifications of the research team.  A biographical sketch is required for
all key personnel, following the instructions below.  No more than three pages
may be used for each person.  A sample biographical sketch may be viewed at:
http://grants.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page;
- List current position(s) and then previous positions;
- List selected peer-reviewed publications, with full citations;
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years.

o  OTHER SUPPORT - Form Page 7.  This form must be completed for applications
in response to this RFA to allow awards to be negotiated and made on or before
September 30, 1999.

o  CHECKLIST - This page should be completed and submitted with the
application.  If the F&A rate agreement has been established, indicate the
type of agreement and the date. It is important to identify all exclusions
that were used in the calculation of the F&A costs for the initial budget
period and all future budget years.

The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information
is necessary following the initial review.

Applications not conforming to these guidelines will be considered
unresponsive to this RFA and will be returned without further review.

The RFA label available in the PHS 398 (rev. 4/98) application form must be
affixed to the bottom of the face page of the application.  Failure to use
this label could result in delayed processing of the application such that it
may not reach the review committee in time for review.  In addition, the RFA
title and number, "Abstinence and HIV/STD Prevention for Youth, MH-99-010,"
must be typed on line 2 of the face page of the application form and the YES
box must be marked.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application must be
sent to:

Willo Pequegnat, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6209 MSC 9619
Bethesda, MD  20892-9619

Applications must be received by May 13, 1999.  If an application is received
after that date, it will be returned to the applicant without review. The
Center for Scientific Review (CSR) will not accept any application in response
to this RFA that is essentially the same as one currently pending initial
review, unless the applicant withdraws the pending application.  The CSR will
not accept any application that is essentially the same as one already
reviewed.  This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIMH staff.  Incomplete and/or non-responsive
applications will be returned to the applicant without further consideration.

Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
the NIMH in accordance with the review criteria stated below.  As part of the
initial merit review, a process will be used by the initial review group in
which applications receive a written critique and undergo a process in which
only those applications deemed to have the highest scientific merit, generally
the top half of the applications under review, will be discussed, assigned a
priority score, and receive a second level review by the appropriate national
advisory council or board.

Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  In
the written comments reviewers will be asked to discuss the following aspects
of the application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals.  Each of these
criteria will be addressed and considered in assigning the overall score,
weighting them as appropriate for each application.  Note that the application
does not need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score.  For example, an
investigator may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.

(1) Significance:  Does this study address an important problem?  If the aims
of the application are achieved, how will scientific knowledge be advanced? 
What will be the effect of these studies on the concepts or methods that drive
this field?

(2) Approach:  Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project?  Does the applicant acknowledge potential problem areas and consider
alternative tactics?

(3) Innovation:  Does the project employ novel concepts, approaches or method?
Are the aims original and innovative?  Does the project challenge existing
paradigms or develop new methodologies or technologies?

(4) Investigator:  Is the investigator appropriately trained and well suited
to carry out this work?  Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?

(5) Environment:  Does the scientific environment in which the work will be
done contribute to the probability of success?  Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements?  Is there evidence of institutional
support?

The initial review group will also examine: the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders,
minorities and their subgroups, and children as appropriate for the scientific
goals of the research and plans for the recruitment and retention of subjects;
the provisions for the protection of human and animal subjects; and the safety
of the research environment.

Schedule

Letter of Intent Receipt Date: April 13, 1999
Application Receipt Date: May 13, 1999
Earliest Anticipated Start Date: August 30, 1999

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Willo Pequegnat, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6209 MSC 9619
Bethesda, MD  20892-9619
Telephone:  (301) 443-6100
FAX:  (301) 443-9719
Email:  wpequegn@nih.gov

Susan Newcomer, Ph.D.
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07 þ MSC 7510
Bethesda, MD  20892-7510
Telephone: (301)435-6981
FAX: (301)496-0962
Email: Snewcomer@nih.gov

June Lunney, Ph.D., R.N.
Division of Extramural Activities
National Institute of Nursing Research
45 Center Drive, Room 3AN-12, MSC 6300
Bethesda, MD  20892-6300
Telephone:  (301) 594-6908
FAX:  (301) 480-8260
Email:  June_Lunney@nih.gov

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115 MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
Email:  Diana_Trunnell@nih.gov

Melinda Nelson
National Institute of Child Health and Human Development
Building 61E, Room 8A07
Bethesda, MD  20892-7510
Telephone:  (301) 496-5481
FAX:  (301) 402-0915
Email:  Nelsonm@nih.gov

Jeff Carow
Grants and Contracts Management Office
National Institute of Nursing Research
Building 45, 3AN-12, MSC 6300
Bethesda, MD  20892-6300
Telephone:  (301) 594-6869
FAX:  (301) 480-8260
Email:  jeff_carow@nih.gov

NIAAA is not co-sponsoring this RFA but is committed to understanding the
complex interaction among psychological/psychiatric processes, drug, and
alcohol abuse among populations at-risk for or infected with HIV/AIDS.  Please
contact Kendall Bryant, Ph.D., Health Scientist Administrator, National
Institute on Alcohol Abuse and Alcoholism, 6000 Executive Boulevard, Room 505,
Rockville, MD 20892-7003 (Fed Exp 20852); Telephone (301) 443-8820; FAX (301)
443-8774; Email: KBRYANT@WILLCO.NIAAA.NIH.GOV.

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.242 (NIMH), 93.865 (NICHD), and 93.361 (NINR).  Awards are made under
authorization of the Public Health Service 5600 Fishers Lane Act, Title IV,
Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and
285) and administered under PHS grants policies and Federal Regulations 42 CFR
52 and 45 CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review. 
Awards will be administered under PHS policy as stated in the NIH Grants
Policy Statement (October 1, 1998).

The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-use of all tobacco products.  In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children.  This is consistent with the
PHS mission to protect and advance the physical and mental health of the
American people.

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